Impurity Profiling - Liquid Vial Product

[Mouleyre]

When Carrying out impurity profiling of a new Drug Product vs RLD in the case of a Liquid vial product - would it be expected by the FDA that for this study the vials should be in inverted position or upright position - or maybe both positions?

[millerk8561]

I would think it would only need to be for the position that is recommended to the customer for storage (upright, I assume), assuming you're testing for formulation impurity and not container impurity (like with leachables analysis).

[Consumer Products Guy]

We had over the counter pharmaceuticals and had samples tilted so that the contents would be in contact with both container and closure.